MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE CATHETER TIP; SYRINGE, PISTON

Model Number 1186000444

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If a sample or additional information is received at a later date, this investigation will be updated.This complaint will be used for qa tracking and trending purposes.

Event Description

The customer reported that the contrast mixture leaked from the syringe and coated all the existing supplies on the table for the procedure.

Manufacturer Narrative

The customer was unable to provide the lot number or the actual device involved in this incident but provided one representative unsealed packaged syringe sample.A complete investigation was performed.The packaging provided with the syringe sample indicated the sample was manufactured from lot 720624x.The syringe sample was received with several clear liquid droplets on the inside of the syringe barrel between the rubber tip and the barrel face.Visual inspection to the quality inspection standard was conducted.Malformation of the rubber tip was observed.The plunger rod and rubber tip were removed from the syringe barrel for evaluation of the rubber tip.Split rubber tip and malformation of the side of the rubber tip was observed.The site¿s lab performed volumetric measurement on the syringe sample.The syringe sample met the specification requirements.Restriction testing and leak testing were performed.The restriction testing is conducted by placing the thumb over the syringe barrel tip and pulling or extending the plunger rod to full barrel capacity to verify that there is no separation of the plunger rod and the rubber tip.The syringe sample passed the restriction test.Leak testing was performed.The leak test was conducted by filling the syringe with water and placing the thumb over the syringe barrel tip and placing pressure on the plunger thumb rest to verify no leakage of water past the rubber tip.The syringe sample failed the leak testing; leakage beyond the first ring of the rubber tip was observed.The device history record for lot 720624x was reviewed and indicated that the product was released accomplishing all quality standards.The defect of split rubber tip which caused syringe to leak was confirmed.Some likely potential root causes for this condition can be due to uneven or insufficient silicone application on the inner dimension of the syringe barrel or inner dimension of barrel too small causing the stopper to drag and split during assembly or the stopper may have been molded and received in this condition.A quality alert will be distributed to heighten awareness to appropriate quality and production personnel.This complaint will be used for tracking and trending purposes.

• Brand Name: 60ML SYRINGE CATHETER TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9500844
• MDR Text Key: 173088732
• Report Number: 1915484-2019-01114
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1186000444
• Device Catalogue Number: 1186000444
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2019
• Patient Sequence Number: 1